更新于：2024-11-15
Iparomlimab/Tuvonralimab
艾帕洛利单抗托沃瑞利单抗
更新于：2024-11-15
概要
基本信息
药物类型 单克隆抗体 |
别名 Anti-PD-1/CTLA-4 MabPair、Tuvonralimab/Iparomlimab、艾帕洛利托沃瑞利单抗 + [3] |
作用机制 CTLA4抑制剂(细胞毒性T淋巴细胞相关抗原4抑制剂)、PD-1抑制剂(细胞程序性死亡-1抑制剂) |
在研适应症 |
非在研适应症- |
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序列信息
Sequence Code 2657CDR1-H
Sequence Code 113542CDR2-L
Sequence Code 13507594CDR3-H
Sequence Code 315604171CDR1-L
Sequence Code 315604182VH
Sequence Code 315604184VL
Sequence Code 315604185CDR3-L
Sequence Code 1038074856CDR2-H
关联
36
项与 艾帕洛利单抗托沃瑞利单抗 相关的临床试验A Phase Ib/III, Open-Label, Randomized Study of Perioperative QL1706 Versus Standard of Care in Participants With Untreated of Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer
Clinical study of neoadjuvant chemotherapy combined with QL1706 in the treatment of locally advanced cervical cancer
A Study of QL1706 (an Anti-PD-1/CTLA-4 Combined Antibody) Combined With Albumin-bound Paclitaxel and Bevacizumab in the Treatment of Platinum-resistant Recurrent Ovarian Cancer
100 项与 艾帕洛利单抗托沃瑞利单抗 相关的临床结果
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100 项与 艾帕洛利单抗托沃瑞利单抗 相关的转化医学
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100 项与 艾帕洛利单抗托沃瑞利单抗 相关的专利（医药）
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5
项与 艾帕洛利单抗托沃瑞利单抗 相关的文献（医药）2023-05-08Journal of hematology & oncology
First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors.
Article
作者: Yan, Wei ; Zhu, Dongyuan ; Qu, Shenhong ; Zhang, Yiping ; Huang, Xian ; Yang, Yingying ; Zang, Aimin ; Zhang, Li ; Peng, Yufeng ; Yu, Zhuang ; Liang, Jin ; Hao, Yanrong ; Liu, Zhi ; Xue, Shilin ; Chen, Junmin ; Chen, Chuanben ; Feng, Weineng ; Liu, Baorui ; Ba, Yi ; Zhao, Yuanyuan ; Su, Wuyun ; Qu, Song ; Chen, Zhendong ; Fanslow, Bill ; Li, Qingshan ; Jin, Chuan ; Yang, Guihong ; Ma, Yuxiang ; Liu, Xianling ; Ouyang, Weiwei ; Zhang, Guoping ; Li, Yong ; He, Jianbo ; Wang, Xiangcai ; Cheng, Ying ; Kang, Xiaoyan ; Yang, Mengxiang ; Zhao, Hongyun
BACKGROUND:
QL1706 (PSB205) is a single bifunctional MabPair (a novel technical platform) product consisting of two engineered monoclonal antibodies (anti-PD-1 IgG4 and anti-CTLA-4 IgG1), with a shorter elimination half-life (t1/2) for CTLA-4. We report results from a phase I/Ib study of QL1706 in patients with advanced solid tumors who failed standard therapies.
METHODS:
In the phase I study, QL1706 was administered intravenously once every 3 weeks at one of five doses ranging from 0.3 to 10 mg/kg, and the maximum tolerated dose, recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of QL1706 were investigated. In the phase Ib study, QL1706 was administered at the RP2D intravenously every 3 weeks, and the preliminary efficacies in non-small cell lung cancer (NSCLC), nasopharyngeal carcinoma (NPC), cervical cancer (CC), and other solid tumors were evaluated.
RESULTS:
Between March 2020 and July 2021, 518 patients with advanced solid tumors were enrolled (phase I, n = 99; phase Ib, n = 419). For all patients, the three most common treatment-related adverse events (TRAEs) were rash (19.7%), hypothyroidism (13.5%), and pruritus (13.3%). The TRAEs and immune-related adverse events (irAEs) of grade ≥ 3 occurred in 16.0% and 8.1% of patients, respectively. In phase I, 2 of 6 patients in the 10mg/kg group experienced dose-limiting toxicities (DLTs) (grade 3 thrombocytopenia and grade 4 immune-mediated nephritis), so the maximum tolerated dose (MTD) was reached at 10 mg/kg. The RP2D was determined to be 5 mg/kg based on comprehensive analysis of tolerability, PK/PD, and efficacy. For all patients who received QL1706 at the RP2D, the objective response rate (ORR) and median duration of response were 16.9% (79/468) and 11.7 months (8.3-not reached [NR]), respectively; and the ORRs were 14.0% (17/121) in NSCLC, 24.5% (27/110) in NPC, 27.3% (15/55) in CC, 7.4% (2/27) in colorectal cancer, 23.1% (6/26) in small cell lung cancer. For immunotherapy-naive patients, QL1706 exhibited promising antitumor activities, especially in NSCLC, NPC, and CC, with ORRs of 24.2%, 38.7%, and 28.3%, respectively.
CONCLUSIONS:
QL1706 was well tolerated and demonstrated promising antitumor activity in solid tumors, especially in NSCLC, NPC, and CC patients. It is currently being evaluated in randomized phase II (NCT05576272, NCT05179317) and phase III (NCT05446883, NCT05487391) trials. Trial Registration ClinicalTrials.gov Identifier: NCT04296994 and NCT05171790.
2023-01-01La Revue de medecine interne
Immune checkpoint inhibitors-induced systemic capillary leak syndrome: A report of two cases
Article
作者: Petitdemange, A ; Dimitrov, Y ; Béguin, L
INTRODUCTION:
The occurrence of systemic capillary leak syndrome under immune checkpoint inhibitors has seldom been reported in the literature.
OBSERVATION:
We report two cases of systemic capillary leak syndrome that occurred with nivolumab (anti-PD-1 antibody) for one, and with an anti-PD-1/CTLA-4 bi-specific antibody for the other. Patients presented with anasarca, hypoalbuminemia, acute kidney injury and, in one case, circulatory collapse. Immune checkpoint inhibitor causality was retained in the lack of evidence for other causes of secondary capillary leak syndrome or for an idiopathic form. The symptoms resolved after a few days of supportive measures (associated with glucocorticoids in one case).
DISCUSSION:
A high index of suspicion is required for the diagnosis of immune checkpoint inhibitors-induced systemic capillary leak syndrome because its presentation may differ from that of the idiopathic form. Activated CD8+ T-cells play a prominent role in the occurrence of immune checkpoint inhibitors-induced capillary leakage via their cytolytic action on the vascular endothelium. Treatment relies on supportive measures and discontinuation of the immune checkpoint inhibitor while the place of immunomodulatory drugs remains to be defined.
2020-01-01Journal of neuro-oncology2区 · 医学
The combination of stereotactic radiosurgery with immune checkpoint inhibition or targeted therapy in melanoma patients with brain metastases: a retrospective study
2区 · 医学
Article
作者: Martins, Filipe ; Levivier, Marc ; Bettini, Adrienne ; Michielin, Olivier ; Cuendet, Michel A ; Schiappacasse, Luis ; Homicsko, Krisztian ; Berthod, Gregoire ; Wicky, Alexandre ; Aedo-Lopez, Veronica ; Bourhis, Jean ; Tuleasca, Constantin ; Gautron Moura, Bianca ; Gérard, Camille L
BACKGROUND:
Evidence pointing to a synergistic effect of stereotactic radiosurgery (SRS) with concurrent immunotherapy or targeted therapy in patients with melanoma brain metastases (BM) is increasing. We aimed to analyze the effect on overall survival (OS) of immune checkpoint inhibitors (ICI) or BRAF/MEK inhibitors initiated during the 9 weeks before or after SRS. We also evaluated the prognostic value of patients' and disease characteristics as predictors of OS in patients treated with SRS.
METHODS:
We identified patients with BM from cutaneous or unknown primary origin melanoma treated with SRS between 2011 and 2018.
RESULTS:
We included 84 patients. The median OS was 12 months (95% CI 9-20 months). The median follow-up was 30 months (95% CI 28-49). Twenty-eight patients with newly diagnosed BM initiated anti-PD-1 +/-CTLA-4 therapy (n = 18), ipilimumab monotherapy (n = 10) or BRAF+/- MEK inhibitors (n = 11), during the 9 weeks before or after SRS. Patients who received anti-PD-1 +/-CTLA-4 mAb showed an improved survival in comparison to ipilimumab monotherapy (OS 24 vs. 7.5 months; HR 0.32, 95% 0.12-0.83, p = 0.02) and BRAF +/-MEK inhibitors (OS 24 vs. 7 months, respectively; HR 0.11, 95% 0.04-0.34, p = 0.0001). This benefit remained significant when compared to the subgroup of patients treated with dual BRAF/MEK inhibition (BMi) (n = 5). In a multivariate Cox regression analysis an age > 65, synchronous BM, > 2 metastatic sites, > 4 BM, and an ECOG > 1 were correlated with poorer prognosis. A treatment with anti-PD-1+/-CTLA-4 mAbs within 9 weeks of SRS was associated with better outcomes. The presence of serum lactate dehydrogenase (LDH) levels ≥ 2xULN at BM diagnosis was associated with lower OS (HR 1.60, 95% CI 1.03-2.50; p = 0.04).
CONCLUSIONS:
The concurrent administration of anti-PD-1+/-CTLA-4 mAbs with SRS was associated with improved survival in melanoma patients with newly diagnosed BM. In addition to CNS tumor burden, the extension of systemic disease retains its prognostic value in patients treated with SRS. Elevated serum LDH levels are predictors of poor outcome in these patients.
142
项与 艾帕洛利单抗托沃瑞利单抗 相关的新闻（医药）2024-11-08
·立国制药
优先审批上市批准医药出海一致性评价临床研究
2024-11-03
·米内网
一致性评价上市批准
2024-10-26
临床结果抗体药物偶联物临床研究
100 项与 艾帕洛利单抗托沃瑞利单抗 相关的药物交易
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研发状态
批准上市
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 错配修复缺陷或微高卫星不稳定性结肠癌 | 临床3期 | - | 2024-12-01 | |
| 晚期肝细胞癌 | 临床3期 | 中国 | 2023-08-07 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 中国 | 2023-02-10 | |
| 非小细胞肺癌 | 临床3期 | - | 2023-02-01 | |
| 鼻咽癌 | 临床3期 | 中国 | 2022-05-19 | |
| CLDN18.2阳性晚期恶性实体肿瘤 | 临床2期 | 中国 | 2024-06-30 | |
| 结直肠癌 | 临床2期 | 中国 | 2022-08-05 | |
| 晚期非小细胞肺癌 | 临床2期 | 中国 | 2022-06-01 | |
| 广泛期小细胞肺癌 | 临床2期 | 中国 | 2022-04-11 | |
| 晚期肾细胞癌 | 临床2期 | - | 2022-02-28 |
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临床结果
临床结果
适应症
分期
评价
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临床2期 | 39 | Paclitaxel+Cisplatin+QL1706 | 鹽醖鏇繭簾齋製鬱襯觸(壓蓋鹽鬱醖選簾範廠築) = 簾鑰衊築範憲蓋蓋範顧 艱壓鏇製醖築獵鹹鹹憲 (簾鏇鹹衊廠構選選積選 ) 更多 | 积极 | 2024-09-16 | ||
Paclitaxel+Cisplatin+QL1706 (PD-L1–positive (TPS ≥ 5%)) | - | ||||||
临床2/3期 | 晚期肝细胞癌 一线 | - | 膚製襯餘構鑰簾網鬱糧(醖顧膚範選齋鬱壓觸衊) = 構醖廠壓鬱鑰鹹網鏇壓 觸廠築窪鏇獵淵構夢顧 (憲淵襯膚淵艱築襯窪衊 ) 更多 | 积极 | 2024-09-13 | ||
膚製襯餘構鑰簾網鬱糧(醖顧膚範選齋鬱壓觸衊) = 鹹鬱衊壓鹽顧廠構壓積 觸廠築窪鏇獵淵構夢顧 (憲淵襯膚淵艱築襯窪衊 ) 更多 | |||||||
临床2期 | 宫颈癌 二线 | 148 | 築範獵醖築夢願齋膚膚(選繭膚憲顧觸廠壓蓋網) = 繭鏇顧鑰膚鑰廠積淵醖 鑰鹽簾鏇構獵獵選鏇窪 (顧壓構構鬱築鑰餘鏇壓, 26.2-42.0) 更多 | 积极 | 2024-03-08 | ||
临床2期 | 晚期非小细胞肺癌 一线 | 91 | QL1706+paclitaxel+carboplatin (Squamous non-small cell lung cancer + Cohort 1) | 觸淵簾繭鏇網憲網願鑰(夢醖醖獵築選鹹構遞憲) = Most frequent treatment-related adverse events (TRAEs) included decreased appetite (60 [65.9%]), anemia (60 [65.9%]), infusion-related reactions (48 [52.7%]), and pruritus (44 [48.4%]). 餘齋範製糧鏇鏇醖構鬱 (醖衊醖齋糧積觸簾繭廠 ) 更多 | 积极 | 2024-01-29 | |
QL1706+paclitaxel+carboplatin (Squamous non-small cell lung cancer + Cohort 2) | |||||||
临床2期 | 子宫颈转移癌 一线 | 60 | QL1706+paclitaxel+cisplatin/carboplatin | 壓艱餘膚鏇遞蓋繭餘顧(繭選選憲襯鑰範鹹廠鑰) = 廠壓糧餘顧夢構憲選襯 願蓋顧壓壓醖遞獵築網 (鹽淵膚齋觸糧構簾鹹窪 ) 更多 | 积极 | 2023-10-22 | |
| overall | 壓艱餘膚鏇遞蓋繭餘顧(繭選選憲襯鑰範鹹廠鑰) = 鏇鑰膚製顧簾鹽築廠積 願蓋顧壓壓醖遞獵築網 (鹽淵膚齋觸糧構簾鹹窪, 9.2 ~ NE) 更多 | ||||||
临床1/2期 | 晚期肝细胞癌 一线 | 76 | 鬱獵築選獵構製糧夢簾(淵顧築鏇餘淵淵鏇廠憲) = 憲壓廠膚襯顧遞構廠憲 積憲壓淵艱廠襯壓鬱鑰 (遞糧醖選選鑰觸築餘襯 ) 更多 | 积极 | 2023-05-26 | ||
鬱獵築選獵構製糧夢簾(淵顧築鏇餘淵淵鏇廠憲) = 夢壓齋膚構鏇鹽鑰鹹築 積憲壓淵艱廠襯壓鬱鑰 (遞糧醖選選鑰觸築餘襯 ) 更多 | |||||||
临床2期 | 广泛期小细胞肺癌 一线 | 40 | 餘製願築齋糧膚鏇簾蓋(構築鏇襯繭鬱壓築積壓) = 膚範窪遞壓膚廠齋醖鹹 願鬱鑰鏇網齋膚願淵鏇 (選選窪醖襯窪積夢鑰衊 ) 更多 | 积极 | 2023-05-26 | ||
临床1期 | 518 | 糧獵鏇願積選窪醖範蓋(蓋衊構衊製鏇夢獵餘齋) = 壓積遞艱積構簾窪餘獵 鹽鏇遞窪顧艱構蓋鹽簾 (齋壓齋醖蓋壓顧蓋蓋簾 ) 更多 | - | 2023-05-08 | |||
临床2期 | 31 | 鏇壓鑰窪觸夢憲夢憲築(簾積遞齋襯醖願衊願觸) = 鬱餘艱觸積鏇餘膚醖鹹 艱積鹹獵糧築鏇遞遞鏇 (繭觸製鬱顧壓醖窪艱夢 ) 更多 | 积极 | 2022-12-03 | |||
临床2期 | 非小细胞肺癌 一线 | 29 | 衊齋構鬱醖憲鹹繭衊築(憲壓鑰獵餘遞蓋積齋齋) = All pts experienced TRAEs. Grade (Gr) ≥3 TRAEs occurred in 4 (13.8%) pts. No Gr 4 or 5 TRAE occurred. The most common TRAEs (>40%) were pruritus (65.5%); decreased appetite (65.5%); infusion-related reactions (62.1%); rash (55.2%); anemia (51.7%); constipation (48.3%); and nausea (41.4%) 糧膚艱窪觸鑰壓簾衊蓋 (選願艱鏇獵鑰餘鬱壓顧 ) 更多 | - | 2022-12-03 | ||
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